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Gilead

Sr Manager, Regulatory Project Management

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

The Senior Manager in Regulatory Project Management will be responsible for the coordination, prioritization and tracking of regulatory activities and submissions associated with the company’s research, development and post-marketing activities for a variety of therapeutic areas. Regulatory activities may include support for both products in early and late stage development and marketed products.

Essential Duties and Job Functions 

Will develop and maintain detailed timelines for global regulatory activities and submissions for assigned therapeutic areas in US, EU, CAN, and Japan, and ensure planning and coordination of activities via the Regulatory Submission Team. 

Will foster effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate, via proactive networking and facilitation of the Regulatory Project Team.

Will initiate or contribute to local and global process improvements within Regulatory Affairs department and cross-functionally which have a significant impact on the business and work collaboratively with other functional areas and Regulatory Affairs’ functions at other sites (including the UK and Canada).

Will also be responsible for: 

  • ensuring regulatory submissions are prepared according to defined Corporate or Regulatory timelines
  • working with Regulatory Regional leads to ensure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures. 
  • tracking regulatory commitments and timelines for maintenance activities such as Postmarketing Commitments and Follow-up Measures, and ensuring appropriate submissions are made in accordance with applicable requirements and deadlines.
  • Strategic oversight of one or more therapeutic areas
  • Managing at least one direct report, as appropriate

Knowledge, Experience and Skills 

Excellent verbal, written, negotiation and interpersonal communication skills are required. Excellent organizational skills and ability to work on a number of projects with tight timelines is required. 

Modest knowledge of regulatory requirements specific to key regions such as the US and EU, and have a general awareness of current global and regional trends in Regulatory Affairs. 

Eight to ten years of relevant experience are required; experience in both Regulatory Affairs and Project Management is sought, and a BA degree in a relevant discipline. An advanced degree and/or PMP certification is preferred.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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